Diagnosis of HIV and Early Antiretroviral Therapy Initiation Among HIV-1 Infected Infants (CDC Detect)

The University of Alabama at Birmingham

Status: Completed

Conditions: Hiv; HIV Infections

Treatments: Diagnostic Test: Alere Q Testing

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03133728

UAB Neo 016

Details and patient eligibility

About

The purpose of the study is to test the effect of the Alere™ q HIV-1/2 Detect (diagnostic assay) on uptake of HIV testing among HIV-exposed infants and young children, and health outcomes for HIV-infected infants and young children using a novel POC EID Community Model in Zambia. The study will also assess the feasibility of field implementation of this novel diagnostic tool and its acceptability among HIV-infected mothers and frontline health workers.

Full description

The purpose of the study is to test the effect of the Alere™ q HIV-1/2 Detect (diagnostic assay) on uptake of HIV testing among HIV-exposed infants and young children, and health outcomes for HIV-infected infants and young children through a novel POC EID Community Model in Zambia. The study will also assess the feasibility of field implementation of this novel diagnostic tool and its acceptability among HIV-infected mothers and frontline health workers. The knowledge generated from this study will enable the Zambia Ministry of Health (MOH) to make informed policy decisions about the implementation and scale up of point of care (POC) diagnostic tools for early infant diagnosis and pediatric HIV treatment programs in Zambia and the region.

Enrollment: 1,682 patients

Sex: All

Ages: 1 minute to 17 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria include IYCs:

1. 0 days (at birth) - 17 months of age;

2. Probable or known HIV exposure documented through maternal sero-positivity or reactive infant HIV antibody test;

3. The IYC must be born to mothers who:

   1. attended ≥1 ANC visits without HIV testing; or
   2. delivered at home and did not return for post-natal care at a health facility, and thus the mother or their child were not tested for HIV; or
   3. were documented as HIV-infected but never initiated ART; or
   4. disengaged from HIV care after ART initiation/have not returned for ARV refills; or
   5. have not returned to the facility with their infant for initial EID testing or follow-up EID testing (after a negative test at birth or 6 weeks); or
   6. IYC not tested 6 weeks after cessation of breastfeeding.

4. With a parent/guardian ≥18 years of age, and willing and able to provide written informed consent in a study language (English, Nyanja, or Bemba).

Exclusion criteria include IYCs:

1. With documented age-appropriate, guideline-adherent receipt of DBS-based EID HIV PCR testing;
2. Already known to be HIV-infected / receiving ART.

Trial design

1,682 participants in 2 patient groups

Pre-Intervention Group

Description:

The Investigators will visit each of the selected 3 clusters (i.e. 6 primary health clinics) to construct a retrospective cohort of high-risk HIV-infected women who entered the national PMTCT program and received the SOC between June 1, 2017 and May 31, 2018. Using existing data through the electronic health record information (SmartCare and LIMS), the investigators will gather individual-level retrospective data on high-risk Mother-Infant Pairs (MIPs) from PMTCT enrolment through the child's ART enrolment, initiation, and retention rate at 3 months.

Post-Intervention Group

Description:

Study Research Assistants (RA) will review routine patient files and registers, augmented by existing electronic health record information, to identify a new cohort of high-risk Mother-Infant Pairs (MIPs) at each study site between the dates of June 1, 2019 and May 31, 2020. The outreach team will include, at a minimum, the study RA, a study peer, and an HIV counselor from the health facility, who will carry the Alere™ q HIV-1/2 Detect with them. When the outreach team contacts a high-risk MIP at community level, the team will approach the MIP for study screening, consent, and enrolment procedures. Study staff will ask the parent/guardian if the parent/guardian would like the IYC to be tested at their home, at a community health post, or other private space in the community. The IYC will be tested using both the Alere™ q HIV-1/2 Detect platform and a reflex DBS PCR test to evaluate performance of the POC platform in a mobile setting against the gold standard.

Treatment:

Diagnostic Test: Alere Q Testing